BEUDAMED
    FDA Enforcement Class II Terminated

    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

    Recall: Z-0040-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0040-2018
    Event ID
    78181
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genesys Orthopedics Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2017
    Initiation Date
    November 5, 2015
    Classification Date
    October 19, 2017
    Termination Date
    July 19, 2018
    Address
    1250 S Capital of Texas Hwy Ste 600, Bldg # 3, West Lake Hills, TX, 78746-6446, United States

    Description

    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

    Reason

    Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

    Code Info

    Lot numbers: 10923, 109231, 11476, 11993, WT20150630A

    Distribution

    US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO

    Quantity

    120 units